Overview of Drug Development: the Regulatory Process. Roger D. Nolan, PhD Director, Project Operations Calvert Research Institute November, 2006. Adapted from course taught by Cato Research. Background:. Roger D. Nolan B.Sc. (Hons), Biochemistry, LaTrobe University, Australia
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Roger D. Nolan, PhD
Director, Project Operations
Calvert Research Institute
Adapted from course taught by Cato Research
The therapeutic index (also known as therapeutic ratio or margin of safety), is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxic effects. Quantitatively, it is the ratio given by the dose required to produce the toxic effect divided by the therapeutic dose. A commonly used measure of therapeutic index is the lethal dose of a drug for 50% of the population (LD50) divided by the effective dose for 50% of the population (ED50).